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Evidence of publication bias in reporting acute stroke clinical trials

From the Comprehensive Stroke Center and Departments of Neurology and Radiology (D.S.L.), University of Pennsylvania, Philadelphia, UCLA Stroke Center and Department of Neurology (D.S.L., C.S.K., J.L.S.), UCLA Medical Center, Department of Biostatistics (J.W.S.), UCLA School of Public Health, and Department of Radiological Sciences (J.W.S.), UCLA School of Medicine, Los Angeles, CA, and Department of Neurology (C.S.K.), Georgetown University, and Washington Hospital Center (C.S.K.), Washington, DC.

Address correspondence and reprint requests to Dr Liebeskind, UCLA Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095; e-mail: davidliebeskind{at}yahoo.com

Objective: To ascertain the extent of publication bias in the reporting of acute stroke clinical trials.

Methods: We identified controlled acute ischemic stroke clinical trials reported in English over a 45-year period from 1955 to 1999 through systematic search of MEDLINE, the Cochrane Controlled Stroke Trials Register, and additional databases. We analyzed trial methodology, quality, outcome, study sponsorship, and timing of publication to identify various forms of publication bias, including nonpublication bias, abbreviated publication bias, and time-lag bias.

Results: One hundred seventy-eight acute ischemic stroke trials, enrolling 73,949 subjects, evaluated 75 agents or nonpharmacologic interventions. A greater proportion of harmful outcomes in unpublished studies (n = 4) compared with published trials (0.75 vs 0.06, p < 0.0001) and underreporting of smaller, nonbeneficial studies in acute stroke suggest nonpublication bias. Although a definite time-lag bias was not evident, nonbeneficial studies were slower to proceed from enrollment completion to publication (2.3 vs 2.0 years, p = 0.207), with an even longer delay for nonbeneficial corporate pharmaceutical sponsored trials (2.8 vs 2.1 years, p = 0.086), despite superior trial report quality scores for corporate-sponsored studies when compared with nonprofit/governmental studies (mean 69.2 ± 95% CI 3.9 vs 53.4 ± 95% CI 9.2, p < 0.005).

Conclusion: Publication bias is evident in the acute stroke research literature, supporting the need for prospective trial registration.

Supported in part by a National Stroke Association Research Fellowship Award (D.S.L.) and NIH-NINDS Awards K23 NS 02088 (C.S.K.) and K24 NS 02092 (J.L.S.).

Disclosures: David S. Liebeskind, MD, has received lecture honoraria or served on the speakers bureau for the following companies: Sanofi, Boehringer Ingelheim, Bristol-Myers Squibb, and ESP Pharma; and has served on the scientific advisory board or as scientific consultant for the following companies: Concentric Medical and CoAxia. Chelsea S. Kidwell, MD, has received lecture honoraria or served on the speakers bureau for the following companies: Sanofi, Boehringer Ingelheim, and Bristol-Myers Squibb; and has served on the scientific advisory board or as scientific consultant for the following companies: Boehringer Ingelheim, Amkor, Daiichi Pharmaceuticals, Glaxo Smith Kline, and Bristol-Myers Squibb/Sanofi. James W. Sayre, PhD, has participated as a Data Safety and Monitoring Board member sponsored by the following companies: Parke Davis and Glaxo Wellcome; and has received lecture honoraria or served as scientific consultant for the following companies: Glaxo Wellcome and MicroTherapeutics. Jeffrey L. Saver, MD, has received lecture honoraria or served on the speakers bureau for the following companies: Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Hoffmann LaRoche, and Sanofi; and has served on the scientific advisory board or as scientific consultant for the following companies: Boehringer Ingelheim, Astra Zeneca, Glaxo Wellcome, Walnut Technologies, Alsius, Bristol-Myers Squibb, Sanofi-Aventis, CoAxia, Takeda, Biosite, Nuvelo, Galileo, Pfizer, Johnson and Johnson, Eli Lilly, Pacificare, Wyeth CSL Ltd., Suntory, and AGA Medical; and has received research support from the following companies: Boehringer Ingelheim, AGA Medical, Concentric Medical, Genentech, and Ekos Corp.

Received December 30, 2005.

Accepted in final form May 10, 2006.

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